BEUDAMED
    FDA PMA 30-Day Notice Accepted 🇺🇸 United States

    PMA: P980001 · Supplement: S031 · Decision Apr 10, 2001
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    NIROYAL(R) ELITE OVER-THE-WIRE STENT SYSTEM
    PMA Number
    P980001
    Supplement Number
    S031
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    April 10, 2001
    Date Received
    March 12, 2001
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    CHANGE IN THE MANUFACTURING PROCESS BY USING SCRAPPED MATERIAL IN THE FINAL FUNCTIONAL TESTING FOR THE SOX(TM) COMPONENT TO MINIMIZE THE AMOUNT OF DESTROYED PRODUCT AT FINAL TESTING.